This is a randomized, two-way crossover, multicenter study evaluating the consumer
preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every
12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every
4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately
250 participants will complete a questionnaire after taking one test product for 3 days
followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for
3 days. Analysis of which product the consumer preferred, if any, and which product was more
convenient, if any, will be evaluated.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Healthy male or female volunteers must be 18 years or older.
- Participants must be willing to stop use of current decongestant and allergy
medications during the study, and at the start of the run-in period (Visit 2).
- Participants must have a documented history of allergic rhinitis caused by ragweed
allergen for at least the prior two years.
- Participants must have a documented skin testing (prick with wheal >= 3 mm larger
than the diluent or intradermal with wheal >=7 mm larger than the diluent control) or
a positive in vitro test for specific IgE to the ragweed allergen within the last
four years.
- Participants must have signs by clinical evaluation and symptoms of nasal congestion
of at least mild severity (sign/symptom clearly present, but minimal awareness;
easily tolerated) at Visit 3 following the run-in period and at visit 5 following the
washout period.
- Clinical laboratory tests (complete hematology, blood chemistries, urinalysis) must
be within normal limits or clinically acceptable to the Investigator/Sponsor. Sponsor
will not grant waivers.
- Participants must have a seated (after 5 minutes of rest) systolic/diastolic blood
pressure ≤ 138/88 mmHg.
- Participants must have normal or clinically acceptable physical exam and
electrocardiogram (ECG) on 12-lead ECG (recorded at 25 mm/s).
- Participants must be free of any clinically significant disease that requires a
physician's care and/or would interfere with study evaluations, procedures or
participation.
- Participants must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days
before study participation and 14 days after the end of the study.
- Participants must be willing to give written informed consent (prior to any study
related procedures being performed) and able to adhere to restrictions and
examination schedules.
- Female participants of childbearing potential (a non-menopausal female who has not
had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure,
including a young woman who has not yet started menstruating) must be using medically
acceptable (documented failure rate of less than 1%) birth control measures. Examples
of medically acceptable contraception include hormonal contraceptives, intrauterine
device (IUD), double-barrier method (any combination of male or female condom,
diaphragm, spermicidal gel, sponge) or sterilization.
- Participants must be able to read and write English, and must understand the dosing
schedule.
Exclusion Criteria:
- Participants must not have any significant medical condition which, in the judgment
of the investigator, is a contraindication to the use of phenylephrine HCl, might
interfere with the study or requires treatment expected to affect the blood pressure.
These may include thyroid disease (e. g. hyperthyroidism, hypothyroidism),
uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease,
elevated intraocular pressure, prostatic hypertrophy, etc.
- Participants that have received allergen immunotherapy or Xolair (omalizumab) therapy
within the past two years.
- Participants who have a history of any clinically significant local or systemic
infectious disease within four weeks prior to initial treatment administration.
- Participants who have participated in a clinical trial of an investigational
treatment within 30 days prior to the start of the study (Run-in Period Day 1).
- Participants who are, appear to be, or are known to be, current or former addicts or
alcoholics.
- Participants who have a known allergy or intolerance to phenylephrine HCl, any other
decongestant, loratadine, desloratadine or any other antihistamine.
- Females who are pregnant, nursing or unwilling to use/practice medically acceptable
contraception (documented failure rate of less than 1%).
- Participants with a history of asthma, rhinitis medicamentosa, or acute or chronic
sinusitis.
- Participants that have used use of inhaled, oral, rectal, topical, intramuscular,
and/or intravenous potent chronic or intermittent corticosteroids (up to 1% topical
hydrocortisone is permitted).
- Participants who work at the study site and/or for the Investigator or are family
members of study staff and/or the Investigator.